Diabetes
Refine Search
Generics
Viatris has disclosed that its oral finished-dose manufacturing facility in Indore, India, is subject to regulatory action from the US regulator, after an inspection earlier this year. 24 December 2024
Generics
The US Food and Drug Administration (FDA) revealed on Monday that it has approved the first generic referencing Victoza (liraglutide injection) 18 milligram/3 milliliter. 24 December 2024
Pharmaceutical
US pharma major Eli Lilly has recently announced a £279 million ($365.5 million) investment in the UK at the International Investment Summit in London. 19 December 2024
Pharmaceutical
The Egyptian Drug Authority has approved EVA Pharma's insulin glargine injection, marking a significant milestone in its collaboration with US pharma major Eli Lilly. 18 December 2024
Pharmaceutical
The European Commission has approved unconditionally, under the EU Merger Regulation, the proposed acquisition of contract development and manufacture organization (CDMO) Catalent (NYSE: MCTLT) by Denmark’s Novo Holdings. 7 December 2024
Biotechnology
Novavax has agreed to sell its manufacturing plant in the Czech Republic to Novo Nordisk for $200 million. 6 December 2024
Pharmaceutical
Novo Nordisk will reduce the US list prices of two insulin products, Tresiba (insulin degludec) and Fiasp (insulin aspart), by over 70% from 2026. 6 December 2024
Pharmaceutical
Eli Lilly has announced a $3 billion investment to expand its recently acquired manufacturing facility in Wisconsin, USA. 6 December 2024
Pharmaceutical
Danish diabetes and obesity giant Novo Nordisk has announced plans to invest 2.9 billion Danish kroner ($410 million) to establish a cutting-edge quality control laboratory in Hillerød, Denmark. 6 December 2024
Biotechnology
Dutch privately held Amarna Therapeutics, which specializes in transformative gene therapies, has entered into a strategic collaboration with Sweden-based NorthX Biologics, a leading biologics manufacturing partner. 4 December 2024
Pharmaceutical
The China-based subsidiary of French pharma major Sanofi revealed it has signed a memorandum of cooperation with Beijing Municipal Bureau of Economy and Information Technology and Beijing Economic and Technological Development Zone today to invest approximately 1 billion euros ($1.05 billion) to establish a new manufacturing base. 3 December 2024
Pharmaceutical
Hua Medicine has announced promising new clinical findings for its glucokinase activator dorzagliatin, presented at the China BioMed Innovation and Investment Conference. 2 December 2024
Pharmaceutical
Australia’s Department of Health and Aged Care has developed a new API (application programming interface) for the efficient distribution of the monthly Pharmaceutical Benefits Scheme (PBS) schedule data. 2 December 2024
Biotechnology
Privately-held UK firm Quell Therapeutics, which positions itself as a pioneer in developing engineered T-regulatory (Treg) cell therapies for serious medical conditions driven by the immune system, has announced that AstraZeneca has selected a candidate to progress in the type 1 diabetes (T1D) Treg cell therapy program. 18 November 2024
Pharmaceutical
French pharma major Sanofi today announced an investment of 40 million euros ($42.4 million) in its Lyon Gerland bioproduction site, consolidating its role as a strategic platform dedicated to immunology. 15 November 2024
Pharmaceutical
Privately-held Montanan firm Microbion has announced promising findings from its Phase II study of pravibismane, a topical treatment aimed at addressing diabetic foot ulcer infections (DFI). 14 November 2024
Pharmaceutical
While sky high expectations for Eli Lilly’s tirzepatide have not yet been realized, more positive data add to a growing sense that the future could be as bright as imagined. 14 November 2024
Pharmaceutical
Germany’s Merck KGaA was trading 5% lower as Thursday’s trading day neared its end, after the company announced its third-quarter financial results and outlook for the rest of the year. 14 November 2024
Pharmaceutical
Anglo-Swedish drugmaker AstraZeneca beat analyst expectations with its third-quarter 2024 revenue and earnings figures. 12 November 2024
Biotechnology
French biotech DiogenX, which is focused on regenerating insulin-producing beta cells for the treatment of diabetes, today announces the appointment of Dr Klara Owen as chief medical officer. 12 November 2024
Pharmaceutical
US pharma major Eli Lily today reported financial result for the first quarter of 2020, posting worldwide revenue of $5.86 billion, an increase of 15% compared with the first quarter of 2019, and above the FactSet consensus of $5.49 billion. The increase in revenue was driven by a 22% increase due to volume, partially offset by a 6% decrease due to lower realized prices. 23 April 2020
Pharmaceutical
The European Commission has granted marketing authorization for Rybelsus (oral semaglutide), for the treatment of adults with insufficiently controlled type 2 diabetes to improve glycemic control as an adjunct to diet and exercise. 6 April 2020
Biosimilars
After contending with quality issues at its new Malaysia plant for several years, Indian biotech Biocon appears to be closer to getting its insulin glargine (Semglee) product onto the US market. 2 April 2020
Pharmaceutical
A new sub-analysis of the landmark Phase III DAPA-HF trial has showed positive efficacy for Farxiga (dapagliflozin) in treating cardiovascular conditions. 30 March 2020
Pharmaceutical
The US Food and Drug Administration has issued a complete response letter (CRL) for the supplemental New Drug Application (sNDA) of the investigational drug empagliflozin 2.5mg as an adjunct to insulin for adults with type 1 diabetes. 23 March 2020
Biotechnology
US clinical-stage biotech Provention Bio yesterday announced a temporary pause in the randomization of patients with newly diagnosed type 1 diabetes (T1D) into its global Phase III PROTECT study of PRV-031 (teplizumab. 17 March 2020
Biotechnology
Once hotly-tipped biotech Intarcia Therapeutics has been dealt a bodyblow from the US regulator, with a second rejection for its drug-device combination ITCA-650. 12 March 2020
Generics
UK-incorporated generics drugmaker Mylan has moved a step nearer to marketing its copy version of Lantus (insulin glargine) in the USA, as the District Court of New Jersey yesterday found the device patent claims (US Patent No 9,526,844) asserted by French pharma major Sanofi against Mylan's insulin glargine product not infringed and invalid for lack of written description. 11 March 2020
Biotechnology
UK company George Health has announced £27 million ($35 million) in new financing to accelerate the commercialization of drugs and technologies for some of the world’s most destructive diseases. 10 March 2020
Pharmaceutical
The US Food and Drug Administration on Monday issued a new draft guidance, “Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control,” to solicit public comment on its proposals for broad safety evaluations before drug approval that look beyond ischemic (reduced blood flow) cardiovascular disease, as well as for the inclusion of a broader scope of human subjects, such as older subjects and those with chronic kidney disease who may be more vulnerable to drug-related side effects. 10 March 2020
Pharmaceutical
Citing positive Phase II data, industry analyst GlobalData says North Carolina, USA-based vTv Therapeutics could become “a strong player in the developing market” for type 1 diabetes (T1D) medicines. 6 March 2020
Biotechnology
Privately-held UK-based T cell receptor (TCR) biotech firm Immunocore today announced the completion of its Series B private financing round, generating more than $130 million. 2 March 2020
Pharmaceutical
Indian drugmaker Sun Pharmaceutical Industries has launched Riomet ER (metformin) in the USA as an adjunct to diet and exercise to improve glycemic control in patients 10 years of age and older with type 2 diabetes mellitus. 26 February 2020
Biotechnology
The US regulator has approved Trulicity (dulaglutide) for the reduction of major adverse cardiovascular events (MACE) in certain adults with type 2 diabetes. 24 February 2020
Biosimilars
India's Biocon, Asia's premier biotechnology company, revealed that the US Food and Drug Administration had conducted a pre-approval inspection of its subsidiary Biocon Sdn BHd's manufacturing facility in Malaysia for insulin glargine between February 10 and 21. 24 February 2020
Biosimilars
Changes that will open up insulins and other biologics to more competition in the US market are now just a month away. 21 February 2020
Biosimilars
Large patent expiry of biologics in the next few years has imparted an increasingly high momentum to the development of biosimilars. 20 February 2020
Generics
Self-reliance is turning out to be key in India as the ongoing novel coronavirus (COVID-19) issue stretches supply chains, reports The Pharma Letter’s local correspondent. 20 February 2020
Pharmaceutical
Japan’s Chugai Pharmaceutical says that both brands of its selective inhibitor of sodium-glucose cotransporter 2 (SGLT2) tofogliflozin hydrate will now be distributed by privately-held Kowa Company. 17 February 2020
Pharmaceutical
Shares of vTv Therapeutics skyrocketed as much as 84.8% to $3.88 pre-market on robust volume, as the US clinical-stage drug developer released positive results from Part 2 of a Phase II clinical trial, Simplici-T1, evaluating TTP399 as oral adjunctive therapy to insulin in adults with type 1 diabetes (T1D). 10 February 2020
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
A US biotech company dedicated to creating oral drugs with an emphasis on indications in virology and immunology.
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze